Regional burden of vaccine-associated menstrual disorders and sexual dysfunction: a retrospective study

Objective: While previous studies have shown that vaccine-induced adverse events differ between sexes, there is still a gap in research analyzing sex-specific reproductive system disorders caused by vaccines. Thus, this study aims to address this gap by identifying the vaccines that most commonly influence the reproductive system in each sex, with a particular focus on menstrual disorders in females and sexual dysfunction in males. Methods: We utilized the international database over 170 countries and territories. We investigated vaccine-associated adverse events associated with menstrual disorders in females and sexual dysfunction in males, across 19 different vaccines. We employed two standard measures of disproportionate analysis: information components (IC) with IC0.25 and reporting odds ratio (ROR) with a 95% confidence interval (CI). Results: Among 4,939,712 cases of all-cause menstrual disorders and 2,964,055 cases of all-cause sexual dysfunction, we identified 147,158 and 2,306 cases of vaccine-associated menstrual disorders and sexual dysfunction, respectively. Menstrual disorders in females showed a significant association with specific vaccines, with COVID-19 mRNA vaccines having the highest magnitude (ROR [95% CI], 49.51 [48.91-50.13]; IC [IC0.25], 3.36 [3.35]), followed by papillomavirus vaccines and Ad5-vectored COVID-19 vaccines. Furthermore, the anthrax vaccine exhibited the highest association with sexual dysfunction in males (ROR, 4.22 [3.04-5.85]; IC, 2.01 [1.45]), followed by COVID-19 mRNA vaccines and Ad5-vectored COVID-19 vaccines. Both menstrual disorders in females and sexual dysfunction in males exhibited a substantial increase between 2010 and 2020. However, the fatality rates associated with these conditions remained extremely low. Conclusions: Our research findings on the influences of vaccines on menstrual disorders and male sexual dysfunction will assist in the development of vaccination strategies that consider the reproductive systems specific to each sex.